Theophylline NDC 46708-025

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0025Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
46708-025-30	46708002530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-30)Marketed from Nov 1, 2010
46708-025-31	46708002531	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-31)Marketed from Nov 1, 2010
46708-025-71	46708002571	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-71)Marketed from Nov 1, 2010
46708-025-91	46708002591	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-91)Marketed from Nov 1, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Theophylline
Generic name (nonproprietary): theophylline
Active ingredients: Theophylline anhydrous — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090430
Marketing start: Nov 1, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 46708-025_0d340b17-907e-4c38-bbd6-c4740495a55aSPL ID 0d340b17-907e-4c38-bbd6-c4740495a55aSPL set ID 31f3c720-1597-4d43-9296-33017b90b15fRxCUI 314241, 317769UNII 0I55128JYK
Pharmacologic class: Methylxanthine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N446708002530 followed by a unit qualifier and the quantity

Package 46708-0025-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 11, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090430

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090430
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-025
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-026
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-026